E coli bioconjugate vaccine(GlaxoSmithKline Plc)(E coli bioconjugate vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

预防性疫苗、重组亚单位疫苗、结合疫苗

别名

ExPEC4V

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Janssen Global Services LLC

非在研机构

Janssen Research & Development LLC

GlycoVaxyn AG

Janssen Pharmaceuticals, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 9931314

关联

4

项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT03819049 / Active, not recruiting临床1/2期

A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

开始日期2019-06-06

申办/合作机构

Janssen Research & Development LLC

NCT03500679 / Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older

The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).

开始日期2018-05-09

申办/合作机构

Janssen Research & Development LLC

NCT02748967 / Completed临床1期

Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.

开始日期2016-04-01

申办/合作机构

Janssen Pharmaceuticals, Inc.

100 项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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11

项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2024-09-03·Journal of Antimicrobial Chemotherapy

A microbiological and genomic perspective of globally collected Escherichia coli from adults hospitalized with invasive E. coli disease

Article

作者: Geurtsen, Jeroen ; Akai, Naomi ; Aitabi, Moussa ; Arconada Nuin, Enya ; Van Puyvelde, Sandra ; Violette, Madison ; Thaden, Joshua ; Kimura, Risa ; Morrow, Brian ; Leten, Gert ; Go, Oscar ; Ruffin, Felicia ; Munshi, Sonal ; Salerno, Nicola Duccio ; Xavier, Basil Britto ; Goossens, Herman ; Spiessens, Bart ; Vilken, Tuba ; Cremonini, Eleonora ; Poolman, Jan ; Cascio, Giuliana Lo ; Walker, Sarah V ; Righi, Elda ; Van Mieghem, Sofie ; Azzini, Anna Maria ; Lammens, Christine ; Palomo, Virginia ; Ekkelenkamp, Miquel ; Espíndola, Reinaldo ; Pascual, Álvaro ; Lakatos, Louis ; Barraud, Olivier ; Bonten, Marc ; Dagher, Michael ; Sarnecki, Michal ; De Blacam, Killian ; Doua, Joachim ; Glupczynski, Youri

AbstractObjectivesEscherichia coli can cause infections in the urinary tract and in normally sterile body sites leading to invasive E. coli disease (IED), including bacteraemia and sepsis, with older populations at increased risk. We aimed to estimate the theoretical coverage rate by the ExPEC4V and 9V vaccine candidates. In addition, we aimed at better understanding the diversity of E. coli isolates, including their genetic and phenotypic antimicrobial resistance (AMR), sequence types (STs), O-serotypes and the bacterial population structure.MethodsBlood and urine culture E. coli isolates (n = 304) were collected from hospitalized patients ≥60 years (n = 238) with IED during a multicentric, observational study across three continents. All isolates were tested for antimicrobial susceptibility, O-serotyped, whole-genome sequenced and bioinformatically analysed.ResultsA large diversity of STs and of O-serotypes were identified across all centres, with O25b-ST131, O6-ST73 and O1-ST95 being the most prevalent types. A total of 45.4% and 64.7% of all isolates were found to have an O-serotype covered by the ExPEC4V and ExPEC9V vaccine candidates, respectively. The overall frequency of MDR was 37.4% and ST131 was predominant among MDR isolates. Low in-patient genetic variability was observed in cases where multiple isolates were collected from the same patient.ConclusionsOur results highlight the predominance of MDR O25b-ST131 E. coli isolates across diverse geographic areas. These findings provide further baseline data on the theoretical coverage of novel vaccines targeting E. coli associated with IED in older adults and their associated AMR levels.

2024-01-01·Journal of Immunology Research

Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer

Review

作者: Ulett, Glen C ; Rahman, Md Mijanur ; Grice, I Darren ; Wei, Ming Q

Antigenic cell fragments, pathogen‐associated molecular patterns, and other immunostimulants in bacterial lysates or extracts may induce local and systemic immune responses in specific and nonspecific paradigms. Based on current knowledge, this review aimed to determine whether bacterial lysate has comparable functions in infectious diseases and cancer treatment. In infectious diseases, including respiratory and urinary tract infections, immune system activation by bacterial lysate can identify and combat pathogens. Commercially available bacterial lysates, including OM‐85, Ismigen, Lantigen B, and LW 50020, were effective in children and adults in treating respiratory tract infections, chronic obstructive pulmonary disease, rhinitis, and rhinosinusitis with varying degrees of success. Moreover, OM‐89, Uromune, Urovac, Urivac, and ExPEC4V showed therapeutic benefits in controlling urinary tract infections in adults, especially women. Bacterial lysate‐based therapeutics are safe, well‐tolerated, and have few side effects, making them a good alternative for infectious disease management. Furthermore, a nonspecific immunomodulation by bacterial lysates may stimulate innate immunity, benefiting cancer treatment. “Coley’s vaccine” has been used to treat sarcomas, carcinomas, lymphomas, melanomas, and myelomas with varying outcomes. Later, several similar bacterial lysate‐based therapeutics have been developed to treat cancers, including bladder cancer, non‐small cell lung cancer, and myeloma; among them, BCG for in situ bladder cancer is well‐known. Proinflammatory cytokines, including IL‐1, IL‐6, IL‐12, and TNF‐α, may activate bacterial antigen‐specific adaptive responses that could restore tumor antigen recognition and response by tumor‐specific type 1 helper cells and cytotoxic T cells; therefore, bacterial lysates are worth investigating as a vaccination adjuvants or add‐on therapies for several cancers.

2021-08-01·Glycoconjugate Journal4区 · 生物学

The development and characterization of an E. coli O25B bioconjugate vaccine

4区 · 生物学

Article

作者: Braun, Martin ; Wetter, Michael ; Wacker, Michael ; Zuppiger, Matthias ; Ravenscroft, Neil ; Kemmler, Stefan ; Kowarik, Michael ; Sirena, Dominique ; De Benedetto, Gianluigi ; Steffen, Michael ; Haeuptle, Micha A ; Cescutti, Paola

AbstractExtraintestinal pathogenic Escherichia coli (ExPEC) cause a wide range of clinical diseases such as bacteremia and urinary tract infections. The increase of multidrug resistant ExPEC strains is becoming a major concern for the treatment of these infections and E. coli has been identified as a critical priority pathogen by the WHO. Therefore, the development of vaccines has become increasingly important, with the surface lipopolysaccharide constituting a promising vaccine target. This study presents genetic and structural analysis of clinical urine isolates from Switzerland belonging to the serotype O25. Approximately 75% of these isolates were shown to correspond to the substructure O25B only recently described in an emerging clone of E. coli sequence type 131. To address the high occurrence of O25B in clinical isolates, an O25B glycoconjugate vaccine was prepared using an E. coli glycosylation system. The O antigen cluster was integrated into the genome of E. coli W3110, thereby generating an E. coli strain able to synthesize the O25B polysaccharide on a carrier lipid. The polysaccharide was enzymatically conjugated to specific asparagine side chains of the carrier protein exotoxin A (EPA) of Pseudomonas aeruginosa by the PglB oligosaccharyltransferase from Campylobacter jejuni. Detailed characterization of the O25B-EPA conjugate by use of physicochemical methods including NMR and GC-MS confirmed the O25B polysaccharide structure in the conjugate, opening up the possibility to develop a multivalent E. coli conjugate vaccine containing O25B-EPA.

100 项与 E coli bioconjugate vaccine(GlaxoSmithKline Plc) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
大肠杆菌感染	临床2期	美国	Janssen Pharmaceuticals, Inc.	2015-11-23
泌尿道感染	临床2期	-	Janssen Global Services LLC	-
泌尿道感染	临床2期	-	GSK Plc	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03500679 (CTgov)	临床2期	-	100	ExPEC4V vaccine (ExPEC4V)	鏇艱鏇願觸觸網糧衊選(餘築網遞範糧淵糧衊艱) = 觸鑰積鬱簾廠鑰選鹽餘鹹遞衊壓積艱築淵築齋 (繭齋願範築築網積襯艱, 網獵淵醖膚繭醖鏇獵範 ~ 願鏇鏇獵簾淵餘繭蓋鹽) 更多	-	2019-11-26
				placebo+ExPEC4V (Placebo)	鏇艱鏇願觸觸網糧衊選(餘築網遞範糧淵糧衊艱) = 鑰蓋淵範鏇選觸膚醖築鹹遞衊壓積艱築淵築齋 (繭齋願範築築網積襯艱, 範糧壓鏇獵齋製觸製範 ~ 築簾淵廠夢積鏇繭淵壓) 更多